Medical Device Reporting Specialist
Job no: 609958
Work type: Permanent
Categories: Quality & Regulatory, Oceania, Individual Contributor
- Friendly, fun, supportive and collaborative team
- Global branded ASX listed double digit growth company
- A global leader in medical devices & hearing loss technologies
Imagine using your experience to help people around the world to hear again. We can offer a unique opportunity to join Cochlear, an iconic Australian company, leading the world in implantable hearing solutions. We are seeking a Medical Device Reporting Specialist to join our Quality team making assessments on reportable adverse events as it pertains to our implantable hearing solutions.
You will ideally have a medical background or have worked in the health industry and be a strong communicator. As part of a small collaborative and collegiate team where you will be well supported.
In this role you will….
- Review complaints, seek further information where required, and make reportability assessments in the timeframe specified as per complaints procedures
- Check that reportability decisions across similar complaints are consistent and where a new approach is required to satisfy regulations, relevant procedures are updated
- Provide expertise and training to those submitting Medical Device reports and Vigilance reports
- Review complaints and compile reports (MDR and vigilance) to ensure relevancy, accuracy and timeliness as per QMS procedures and regulations/standards 21 CFR Part 803, ISO 13485 and EN ISO 13485
- Assess if complaints require investigation per the QMS procedures and document root cause and corrective actions if relevant
To be successful in this role you will have……
- Tertiary qualifications in medical science, health, biological science, nursing or related discipline
- Clinical/health experience with working knowledge of medical terminology
- Critical/analytical thinker with strong attention to detail
- Ability to work effectively both independently and as a member of a cross-functional team
- Strong communication skills with demonstrated ability to collaborate
What we can offer……
- An engaging workplace and the opportunity to work with progressive and dedicated colleagues, and where your daily tasks give you purpose
- A variety of opportunities to demonstrate your skills and develop some new ones
- The opportunity to work within large, multi-disciplinary project teams
- Exposure to a medical regulatory environment in a global organisation
- A competitive salary package and benefits with flexible working conditions
This is your chance to be part of a premier organization with a great culture, working in a dynamic, growing and rapidly evolving environment to deliver outstanding results that benefit our customers every day. Be part of something purposeful and APPLY now by clicking on the link below and see your career grow!
Cochlear’s mission is to help people hear and be heard. Around the world, more people chose a Cochlear-branded hearing implant system than any other. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people’s lives. Learn and grow with us as we tackle the most complex challenges in helping people to Hear Now. And Always. Cochlear is the global market leader in implantable hearing solutions including cochlear implant systems (CI) and bone anchored hearing aids (Baha™).
Advertised: AUS Eastern Standard Time
Applications close: AUS Eastern Standard Time
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